Humiome® Post LB for Gastrointestinal Symptoms

Overseen By Erin Lewis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DSM Nutritional Products, Inc.

Must not be taking: Antibiotics, Prebiotics, Probiotics, Postbiotics

Disqualifiers: IBS, Diabetes, Cardiovascular, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on bowel movements in healthy adult volunteers compared to Placebo adjusted on baseline. The main question\[s\] it aims to answer \[is/are\]: Does Humiome ® Post LB improve bowel movements with self-reported GI issues? Participants will be provided Humiome ® Post LB (170 mg) for 8 weeks and asked to complete a study diary, questionnaires, and stool samples.

Will I have to stop taking my current medications?

The trial requires participants to avoid taking prebiotic, probiotic, postbiotics, fiber-rich and dietary supplements, anti-diarrheal, and anti-constipation medications during the study. Other medications may be allowed if they are part of your current habits and approved by the study team.

How does the treatment Humiome® Post LB differ from other treatments for gastrointestinal symptoms?

Humiome® Post LB may be unique due to its potential use of probiotics like Lactobacillus plantarum 299 v, which has shown benefits in relieving abdominal pain in irritable bowel syndrome (IBS) patients. This approach differs from traditional treatments that often focus on dietary changes or antibiotics for conditions like small intestinal bacterial overgrowth (SIBO). ^{1 2 3 4 5}

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

This trial is for healthy adults who have self-reported gastrointestinal issues and are interested in improving their bowel movements. Participants will be required to keep a study diary, fill out questionnaires, and provide stool samples over an 8-week period.

Inclusion Criteria

Be able to give written informed consent

My BMI is between 18.5 and 29.9.

I agree to keep my diet, lifestyle, and medication habits the same during the study.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Currently consuming a vegetarian or vegan diet

Are planning a holiday over the study period that would alter dietary patterns as assessed by the QI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Humiome® Post LB (170 mg) or placebo for 8 weeks and complete a study diary, questionnaires, and provide stool samples.

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Humiome® Post LB

Trial Overview The trial is testing the effects of Humiome® Post LB (170 mg), a supplement taken for 8 weeks, on bowel movement regularity compared to a placebo. The study uses a double-blind design where neither participants nor researchers know who receives the actual supplement or placebo.

Participant Groups

Group I: Humiome® Post LB Experimental Treatment 1 Intervention

A postbiotic comprised of inactivated Limosilactobacillus fermentum (CNCM I-2998) and Lactobacillus delbrueckii (CNCM I-4831), together referred to as Lactobacillus LB, and fermented culture medium.

Group II: Placebo Placebo Group 1 Intervention

170 mg/day of micro-crystalline cellulose

Who Is Running the Clinical Trial?

DSM Nutritional Products, Inc.

Lead Sponsor

Trials

98

Recruited

57,600+

Dimitri de Vreeze

DSM Nutritional Products, Inc.

Chief Executive Officer since 2021

MBA from INSEAD, MSc in Civil Engineering from ETH Zurich

Mauricio Adade

DSM Nutritional Products, Inc.

Chief Marketing Officer since 2010

Not available

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term gastrointestinal tolerance of NUTRIOSE FB in healthy men. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial: effect of Lactobacillus plantarum 299 v on symptoms of irritable bowel syndrome. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Small Intestinal Bacterial Overgrowth. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Fiber, food intolerances, FODMAPs, gluten and functional gastrointestinal disorders--update 2014]. [2017]

5. Iran pubmed.ncbi.nlm.nih.gov

New insights in IBS-like disorders: Pandora's box has been opened; a review. [2022]